Stelara Succeeds in Psoriatic Arthritis

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Note that this study was published as an abstract and presented at a conference. These data and conclusions should be considered to be preliminary until published in a peer-reviewed journal.

Ustekinumab yielded significant and sustained improvements in signs and symptoms of psoriatic arthritis in both anti-TNF-naive and anti-TNF-experienced patients.

MADRID -- The monoclonal antibody ustekinumab (Stelara) had sustained benefits through a year of treatment among patients with active psoriatic arthritis, even for those who had previously not done well on a tumor necrosis factor (TNF) inhibitor.

Among those who had not previously received anti-TNF treatment, patients who saw a 20% improvement in their symptoms according to the criteria of the American College of Rheumatology (ACR20) ranged from 59% to 73% on ustekinumab (Stelara), Christopher Ritchlin, MD, of the University of Rochester in New York, reported here at the annual meeting of the European League Against Rheumatism.

And even among those who had already been given anti-TNF treatment but had stopped, whether for a lack of efficacy or adverse events, 50% to 55% showed ACR20 responses at week 52, Ritchlin and his colleagues found.

"Little has been known about treatment options for patients with psoriatic arthritis who haven't responded to either methotrexate or anti-TNF treatment -- patients who don't really have any good alternatives," Ritchlin said at a press briefing.

A previous study found that patients with active psoriatic arthritis who had not had an adequate response to methotrexate showed benefits with ustekinumab.

This agent is a monoclonal antibody targeting interleukins 12 and 23, which binds to p40 on natural killer and T cells and blocks subsequent immune events, he explained.

To see if the response extended to patients who also had failed on other biologics, he and his colleagues enrolled 312 patients, randomizing them to receive ustekinumab 45 mg or 90 mg at baseline, 1 month, and then every 3 months.

A control group was given placebo at baseline, 1 month, and month 4 followed by crossover to 45 mg ustekinumab at weeks 24, 28, and 40.

After 4 months, patients who had less than 5% improvement in their tender and swollen joint counts were switched. If they had been on placebo, they were given ustekinumab 45 mg, and if they had been on the 45 mg dose, they were switched to the 90 mg dose.

A total of 180 of the patients had previously received anti-TNF therapy. Of those, the baseline tender and swollen joint counts were 25 and 14, respectively.

At week 24, 43.8% of patients receiving ustekinumab had ACR20 responses compared with 20.2% of patients on placebo (P<0.001), said Ritchlin.

By 1 year, among patients receiving the 45 mg dose, 47% had ACR20 responses, while 28% and 13% had ACR50 and ACR70 responses.

For patients given the 90 mg dose, the corresponding numbers were 48%, 26%, and 18%.

The ACR20 responses among patients who had been anti-TNF naive were 40% in patients originally randomized to placebo and then switched, 60% in the original 45-mg group, and 58.5% in the 90-mg group, while that response was seen in 37% and 41% of the TNF-experienced group.

Even among patients who had received three or more anti-TNF agents, 29% of the 45-mg group had ACR20 responses, as did 13% of the 90-mg group.

Improvements in psoriasis skin scores of 75% or more were seen in 56% of patients originally receiving placebo and then given 45 mg, while that degree of improvement was seen in 57% and 64% of the initial 45 and 90 mg groups, respectively.

Serious adverse events were seen in 5.8% of both dose groups, which was similar to the placebo group, and events leading to discontinuation occurred in 5.8% and 3.8% of the 45-mg and 90-mg groups.

Two patients, both of whom had previously been treated with anti-TNF therapy, developed malignancies. One of these was breast cancer, in a patient receiving the 45 mg dose, and the other was squamous cell carcinoma in a patient on 90 mg.

"This study showed that for patients who have had to stop an anti-TNF agent for some reason, ustekinumab is effective. So we now have an alternative for these patients, and it represents a major advance for those of us who treat this disease," he said.

"Moreover, for dermatologists who treat patients with psoriasis and who may also have joint involvement, they can be reassured that this agent has effects on the joints as well," he added.

"In some of these patients in the dermatologists' offices, they have arthritis that's not been diagnosed. So for those patients, whether or not they've been exposed to anti-TNF, there's a reasonable chance that this agent will not only work for their skin but also for their joints," he told MedPage Today.

The study was supported by Janssen Research and Development.

The investigators disclosed receiving support from Janssen R&D and being employees of the company.

Reviewed by Zalman S. Agus, MD Emeritus Professor, Perelman School of Medicine at the University of Pennsylvania and Dorothy Caputo, MA, BSN, RN, Nurse Planner